Diet, Cardiometabolic Risk (CM) and Menopause Symptoms

Menopause Clinical Trial

Official title:

Dietary Patterns, Cardiometabolic Risk Factors and Menopause Symptoms in a Sample of UK Women - A Randomised Cross-over Parallel Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05764473
• Other study ID #: MenoUoC
• Status: Recruiting
• Phase: N/A
• Start date: March 14, 2023
• Est. completion date: July 31, 2023

Study information

• Verified date: April 2023
• Source: University of Chester
• Contact: Tanja Harrison, PhD
• Phone: 01244511224
• Email: t.harrison[@]chester.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research will explore the question 'What impact do the Mediterranean Diet (MedDiet) and the Heart UK Ultimate Cholesterol Lowering Plan (UCLP) Menopause have on cardiometabolic risk factors and the frequency and severity of menopause symptoms? This is a randomised cross-over parallel trial of 12 weeks duration. Participants are women undergoing or having completed the menopause transition.

Description:

Group 1 will first follow the MedDiet pattern for six weeks and then follow the UCLP diet pattern for six weeks. Group 2 will also follow both diet patterns but in the opposite order.

Week 0 will be the baseline, week 6 will be the interim point and week 12 will be the endpoint.

Data collection Some data will be collected at the University of Chester laboratories, including anthropometric measurements, blood pressure and blood samples. A small fasted blood sample will be collected via finger prick (Alere Cholestech LDX® Analyzer (Alere San Diego Inc. USA)). Participants will also be talked through the guidance notes for the diets at this point. Other data, food diaries and a questionnaire asking about recent physical activity and menopause symptoms will be completed online.

Demographics At baseline participants will be asked to complete a brief questionnaire to answer a few demographic questions, including date of birth, ethnicity, income category, level of education, whether (and if so which) using any form of hormone replacement therapy (HRT) or contraception. Participants will be asked at interim and endpoint whether there have been any recent changes with regards to HRT and contraception methods.

Dietary intake Participants will be asked to complete a total of seven four-day food diaries. The first diary will be completed in the week before participants attend their first appointment in the laboratory. This diary will give a snapshot of the participants' habitual diet prior to joining the intervention. The other four-day food diaries will be completed in weeks 2, 4, 6, 8, 10 and 12.

Physical activity Data on physical activity over the previous four-week period will be collected at baseline, interim point and endpoint. Participants will be asked to complete the Recent Physical Activity Questionnaire (RPAQ).

Data analysis Blood sample Blood samples will be used to assess whether participants have

• elevated total cholesterol levels (>5 mmol/L)

• elevated LDL cholesterol levels (>3.0 mmol/L)

• elevated non-HDL cholesterol levels (>4 mmol/L)

• decreased HDL cholesterol levels (<1.3 mmol/L)

• elevated triglyceride levels (>1.7 mmol/L)

• elevated glucose levels (> 5.6 mmol/L)

HDL-C, glucose and triglyceride levels will also be used together with waist circumference and blood pressure data to assess whether participants present with metabolic syndrome at baseline, interim point and endpoint according to the definition of Alberti et al. (2009)

Dietary intake Food diary data will be analysed using the dietary assessment software Nutritics (2021).

The data from the analysis will also be used to identify the intake of phytoestrogen-rich foods (associated with milder menopause symptoms) and the average intake of phytoestrogens.

Dietary adherence and diet quality Following on from the analysis of the food diaries adherence to the MedDiet will be assessed by applying the Mediterranean Diet Score.

Adherence to the UCLP Menopause will be assessed by applying an amended version of the Portfolio Diet Score. The scoring system will be slightly adjusted where there are differences in terms of amounts to be consumed of the four portfolio foods.

Physical activity Each activity across the four domains of the RPAQ has a MET score assigned based on Ainsworth et al.'s (2011) updated Compendium of Physical Activities to categorise the activity as sedentary, light, moderate or vigorous intensity. Recoding of the completed RPAQ will follow the script devised by Medical Research Council (MRC) Epidemiology Unit (Scott et al., 2013; available to download at www.mrc-epid.cam.ac.uk/physical-activity-downloads/).

Statistical analysis Descriptive statistics (means (M) and standard deviation (SD)) will be produced for all data collected. Data will also be analysed for correlations between dietary intake, diet quality and changes to cardiometabolic risk (CMR) and to menopause symptoms. Mixed ANOVAs and linear and logistic regression analysis will also be employed. If necessary data will be adjusted for factors, such as physical activity, ethnicity, HRT intake, contraceptive intake, educational level and income category.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: July 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years and older

Eligibility

Inclusion Criteria:

• over the past year presented with any of the following

1. Irregular periods or no periods at all

2. Night sweats

3. Hot flushes

4. Sleeplessness

5. Brain fog

6. Increased anxiety

7. Joint pain

8. Changes to hair or skin

Exclusion Criteria:

• Ever had an eating disorder

• Ever diagnosed with cardiovascular disease or type 2 diabetes

• Ever diagnosed with kidney disease

• Current smoker

• Triglyceride levels of = 5.7 mmol/L at baseline

• Glucose levels of = 7 mmol/L at baseline

• Diastolic blood pressure of = 100 mmHg at baseline

• Systolic blood pressure of = 160 mmHg at baseline

Related Conditions & MeSH terms

• Menopause
• Metabolic Syndrome
• Metabolic Syndrome, Protection Against

Intervention

Other:
• The impact of MedDiet on cardiometabolic risk factors and menopause symptoms
12-week randomised parallel cross-over study with 32 participants. Impact of diet on CMR factors and menopause symptoms will be explored with diet quality and adherence to diet determined via diet quality indices for MedDiet and Portfolio diet.
• The impact of UCLP on cardiometabolic risk factors and menopause symptoms
12-week randomised parallel cross-over study with 32 participants. Impact of diet on CMR factors and menopause symptoms will be explored with diet quality and adherence to diet determined via diet quality indices for MedDiet and Portfolio diet.

Locations

Country	Name	City	State
United Kingdom	University of Chester	Chester	Cheshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Chester

Country where clinical trial is conducted

United Kingdom, 

References & Publications (5)

El Khoudary SR, Aggarwal B, Beckie TM, Hodis HN, Johnson AE, Langer RD, Limacher MC, Manson JE, Stefanick ML, Allison MA; American Heart Association Prevention Science Committee of the Council on Epidemiology and Prevention; and Council on Cardiovascular — View Citation

Gomez-Delgado F, Katsiki N, Lopez-Miranda J, Perez-Martinez P. Dietary habits, lipoprotein metabolism and cardiovascular disease: From individual foods to dietary patterns. Crit Rev Food Sci Nutr. 2021;61(10):1651-1669. doi: 10.1080/10408398.2020.1764487. — View Citation

Greene JG. Constructing a standard climacteric scale. Maturitas. 1998 May 20;29(1):25-31. doi: 10.1016/s0378-5122(98)00025-5. — View Citation

Lobo RA, Gompel A. Management of menopause: a view towards prevention. Lancet Diabetes Endocrinol. 2022 Jun;10(6):457-470. doi: 10.1016/S2213-8587(21)00269-2. Epub 2022 May 5. — View Citation

Roa-Diaz ZM, Raguindin PF, Bano A, Laine JE, Muka T, Glisic M. Menopause and cardiometabolic diseases: What we (don't) know and why it matters. Maturitas. 2021 Oct;152:48-56. doi: 10.1016/j.maturitas.2021.06.013. Epub 2021 Jul 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change Total cholesterol baseline-interim point	Change from baseline total cholesterol concentrations at 6 weeks	6 weeks
Primary	Change Total cholesterol baseline-endpoint	Change from baseline total cholesterol concentrations at 12 weeks	12 weeks
Primary	Change Total cholesterol interim point - endpoint	Change from interim point total cholesterol concentrations at 12 weeks	6 weeks
Primary	Change HDL cholesterol baseline - interim point	Change from baseline HDL cholesterol concentrations at 6 weeks	6 weeks
Primary	Change HDL cholesterol baseline - endpoint	Change from baseline HDL cholesterol concentrations at 12 weeks	12 weeks
Primary	Change HDL cholesterol interim point - endpoint	Change from interim point HDL cholesterol concentrations at 12 weeks	6 weeks
Primary	Change LDL cholesterol baseline-interim point	Change from baseline LDL cholesterol concentrations at 6 weeks	6 weeks
Primary	Change LDL cholesterol baseline - endpoint	Change from baseline LDL cholesterol concentrations at 12 weeks	12 weeks
Primary	Change LDL cholesterol interim point - endpoint	Change from interim point LDL cholesterol concentrations at 12 weeks	6 weeks
Primary	Change non-HDL cholesterol baseline - interim point	Change from baseline non-HDL cholesterol concentrations at 6 weeks	6 weeks
Primary	Change non-HDL cholesterol baseline - endpoint	Change from baseline non-HDL cholesterol concentrations at 12 weeks	12 weeks
Primary	Change non-HDL cholesterol interim point - endpoint	Change from interim point non-HDL cholesterol concentrations at 12 weeks	6 weeks
Primary	Change triglycerides baseline - interim point	Change from baseline triglyceride concentrations at 6 weeks	6 weeks
Primary	Change triglycerides - baseline - endpoint	Change from baseline triglyceride concentrations at 12 weeks	12 weeks
Primary	Change triglycerides interim point - endpoint	Change from interim point triglyceride concentrations at 12 weeks	6 weeks
Primary	Change blood glucose baseline - interim point	Change from baseline blood glucose concentrations at 6 weeks	6 weeks
Primary	Change blood glucose baseline - endpoint	Change from baseline blood glucose concentrations at 12 weeks	12 weeks
Primary	Change blood glucose interim point - endpoint	Change from interim point blood glucose concentrations at 12 weeks	6 weeks
Primary	Change Systolic and diastolic blood pressure baseline - interim point	Change from baseline systolic and diastolic blood pressure at 6 weeks	6 weeks
Primary	Change Systolic and diastolic blood pressure baseline - endpoint	Change from baseline blood glucose concentrations at 12 weeks	12 weeks
Primary	Change Systolic and diastolic blood pressure - interim point - endpoint	Change from interim point blood glucose concentrations at 12 weeks	6 weeks
Primary	Change Body mass index - baseline - interim point	Change from baseline body mass index at 6 weeks	6 weeks
Primary	Change Body mass index baseline - endpoint	Change from baseline body mass index at 12 weeks	12 weeks
Primary	Change Body mass index - interim point - endpoint	Change from interim point body mass index at 12 weeks	6 weeks
Primary	Change Waist circumference baseline - interim point	Change from baseline waist circumference at 6 weeks	6 weeks
Primary	Change Waist circumference baseline - endpoint	Change from baseline waist circumference at 12 weeks	12 weeks
Primary	Change Waist circumference interim point - endpoint	Change from interim point waist circumference at 12 weeks	6 weeks
Primary	Change Waist-hip ratio baseline - interim point	Change from baseline waist-hip ratio at 6 weeks	6 weeks
Primary	Change Waist-hip ratio baseline - endpoint	Change from baseline waist-hip ratio at 12 weeks	12 weeks
Primary	Change Waist-hip ratio interim point - endpoint	Change from interim point waist-hip ratio at 12 weeks	6 weeks
Primary	Change Waist-height ratio baseline - interim point	Change from baseline waist-height ratio at 6 weeks	6 weeks
Primary	Change Waist-height ratio baseline - endpoint	Change from baseline waist-height ratio at 12 weeks	12 weeks
Primary	Change Waist-height ratio interim point - endpoint	Change from interim point waist-height ratio at 12 weeks	6 weeks
Secondary	Change Frequency of menopause symptoms baseline - interim point	Change from baseline frequency of menopause symptoms at 6 weeks on a scale from 0 to 21 on the Greene Climacteric Scale. Higher Scores indicate higher frequency.	6 weeks
Secondary	Change Frequency of menopause symptoms baseline - endpoint	Change from baseline frequency of menopause symptoms at 12 weeks on a scale from 0 to 21 on the Greene Climacteric Scale. Higher Scores indicate higher frequency.	12 weeks
Secondary	Change Frequency of menopause symptoms - interim point - endpoint	Change from interim point frequency of menopause symptoms at 12 weeks on a scale from 0 to 21 on the Greene Climacteric Scale. Higher Scores indicate higher frequency.	6 weeks
Secondary	Change Severity of menopause symptoms baseline - interim point	Change from baseline severity of menopause symptoms at 6 weeks on a scale from 0 to 3 on the Greene Climacteric Scale. Higher Scores indicate higher severity.	6 weeks
Secondary	Change Severity of menopause symptoms baseline - endpoint	Change from baseline severity of menopause symptoms at 12 weeks on a scale from 0 to 3 on the Greene Climacteric Scale. Higher Scores indicate higher severity.	12 weeks
Secondary	Change Severity of menopause symptoms interim point - endpoint	Change from interim point severity of menopause symptoms at 12 weeks on a scale from 0 to 3 on the Greene Climacteric Scale. Higher Scores indicate higher severity.	6 weeks